Principal Biostatistician
Biotech
We are seeking a Principal Biostatistician to join a growing biotech company. This role offers the opportunity to contribute to the development of innovative therapies by leading statistical strategy and execution for clinical trials across multiple phases. The ideal candidate has a strong background in biostatistics, regulatory submissions, and cross-functional collaboration.
Key Responsibilities
- Provide statistical leadership in the design, execution, and analysis of clinical trials (Phases I-III).
- Develop statistical methodologies and analysis plans, ensuring compliance with regulatory guidelines (FDA, EMA).
- Collaborate cross-functionally with clinical, regulatory, and data management teams to optimize trial design and interpretation of study results.
- Lead statistical input for regulatory submissions, including ISS/ISE, clinical study reports, and briefing documents.
- Oversee programming and validation of statistical outputs, ensuring accuracy and reproducibility.
- Represent biostatistics in meetings with regulatory agencies and key stakeholders.
- Stay up to date with industry trends and innovative statistical approaches.
Qualifications
- Master’s or Ph.D. in Biostatistics, Statistics, or a related field.
- 8+ years of experience in biostatistics within the biotech or pharmaceutical industry.
- Strong knowledge of clinical trial design, survival analysis, and statistical modeling.
- Experience with regulatory submissions and interactions with health authorities.
- Proficiency in SAS and/or R, with the ability to oversee statistical programming activities.
- Excellent communication skills and ability to work effectively in a cross-functional team.